Post Approval Activities
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You have done all the development work, the nonclinical studies, the clinical studies and formulation development. You have completed your CTD. You have submitted your application to your Competent Authority, and maybe answered a few questions, and now you have a marketing authorisation. You can now market that product, subject to any pricing and reimbursement issues.
However the regulatory work does not stop with product launch. It would be quite unusual if further regulatory activity was NOT needed after a marketing authorisation has been granted, but not all of them can be anticipated and factored into your proactive regulatory management. Often you have to respond rapidly to stay in compliance whist also maintaining supply of the product to patients.
What if you have planned your annual regulatory activities only to be faced with an instruction from a health authority agency to urgently implement a change to your MA within a short time frame? How do you manage the necessary resource and bring in experienced regulatory professionals? Akos can provide that additional capacity to ensure your submissions are managed effectively, prepared and submitted in time to meet that deadline.
What happens when your manufacturing site for your dosage form is unable to maintain supply and you have to locate, and move all your production to another site? Do you have the capacity and know-how needed to overcome the regulatory hurdles associated with moving production? Akos can review your crisis, advise on regulatory options for getting production back on track and provide that essential regulatory assistance.
And what if an unexpected safety issue means you have to change all your labelling? Can you quickly assemble the necessary Type II variation with all the mock-ups? And will you need user testing? Akos can prepare your variation, coordinate translations and Braille as necessary and submit your variation through whichever route is appropriate to cover all your EU licences.
In fact, Akos can manage all regulatory activities for your product or portfolio and advise on lifecycle management.
Whether you are a small company or large multinational company, Pharma Rx or OTC, start-up company or established company Akos can provide you with the necessary regulatory support to meet the demanding requirements for current pharmaceutical legislation post authorisation. With its team of eight regulatory professionals with combined experience of more than 170 years in the pharmaceutical industry and working from a modern, fully IT equipped office in Hertfordshire in the UK, Akos can provide you with the means to meet your deadline, keep supply of that product to patients, and stay in compliance.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk